An Integrated Artificial Intelligence Based System for Monitoring and Remediating Withdrawal Symptoms

ABSTRACT

In neonates or infants, the system identifies Neonatal Abstinence Syndrome (NAS) and in adult patients the system monitors for and identifies withdrawal and/or relapse symptoms. The system can be used for NAS babies in hospitals as well as in the home for adults. The system obtains biosensor or behavioral information about a patient from a wearable device on the patient and makes a determinative recommendation based on algorithm driven calculations and takes appropriate action based on its evaluation. The biosensor and behavioral information are collected by way of a wearable device, high precision cameras, muti pitch microphones over progressive periods of time. When the data is indicative of a need for treatment because the patient is exhibiting symptoms or indicating relapse traits, this information is sent to the system where an AI module further predicts and recommends a delivery of treatment for the patient.

BACKGROUND OF THE INVENTION

CROSS REFERENCES TO RELATED APPLICATIONS This application claims thebenefit of U.S. Pat. Application No. 17/528,721, filed on Nov. 17, 2021entitled “SYSTEM FOR IDENTIFYING AND REMEDIATING PATIENT WITHDRAWLSYMPTOMS”, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

Embodiments of the invention relate to the field of identifying andremediating patient withdrawal symptoms. In neonates or infants, thesystem identifies Neonatal Abstinence Syndrome (NAS) and in adultpatients the system monitors for and identifies withdrawal and/orrelapse symptoms. More specifically, one or more embodiments of theinvention are directed to a drug delivery management system for managinga patient’s drug craving and withdrawal by sensing and monitoringhemodynamic, physiological and environmental data and administeringeffective amounts of a drug to control or prophylactically treat drugrelated withdrawal.

BACKGROUND

In 2017, the U.S. government declared the opioid crisis a public healthemergency and called for action to address a rapidly escalating nationalepidemic of drug use. Physiological dependence can occur after a patienthas been consuming daily dosages of opioids (either prescriptionpainkillers or heroin) typically for three weeks or longer. Oncephysiological dependence is manifest, opioid dosage reduction orcomplete cessation will cause acute opioid withdrawals. Clinical signsand symptoms of opioid withdrawals include dysphoria, anxiety,restlessness, gastrointestinal distress, tachycardia and flu-likesymptoms. Depending on the exact type of opioid that the patient hasconsumed, these withdrawal symptoms will onset as soon as a few hoursafter the last opioid intake. Typical durations for opioid withdrawalsymptoms range from several days to a few weeks. Untreated opioidwithdrawals, albeit rarely life threatening, can be very uncomfortablefor the patient and often result in relapse to opioid use.

To break through this vicious cycle, the first step for patients whoseek to stop taking opioids is to undergo medically supervised opioidwithdrawal, also referred to as “detoxification.” There are bothinpatient and outpatient facilities available where patients receivemedication to reduce the severity of their withdrawal symptoms. Oncedetoxification is completed successfully, most patients will require aso-called “maintenance treatment” that is long-term in nature to preventrelapse. In fact, opioid use disorder is generally a chronic condition(comparable to high-blood pressure or asthma) for which most patientsrequire a life-long “maintenance” treatment (after detoxification),consisting of a medication-assisted therapy (MAT) to suppress drugcravings and relapse.

Currently, the most typical maintenance treatment consists of dailyadministering either methadone or buprenorphine (“BUP”), accompanied bypsychotherapy and drug counseling. In the U.S. methadone is a scheduleII controlled substance subject to strict regulatory requirements thatlimit access and the settings in which the drug can be offered topatients. Buprenorphine on the other hand is schedule III drug that canbe prescribed in a clinician’s office for both detoxification andmaintenance treatment. It is currently available as sublingual tablets(with and without the opioid antagonist naloxone), a passive transdermalpatch, an implant that provides a low, steady dose for six months, along-term injection (duration: 1 month). Both the implant and theinjectable formulation are indicated after the patient has achievedclinical stability with sublingual buprenorphine at a daily dose of 8 mgor less. While there are no clinical studies published yet on theefficacy of the long-term injectable formulation, a randomized trialwith 163 patients over six months has demonstrated the efficacy of theimplant formulation.

Despite such available modalities, there remains concerns regarding thegeneral method of drug administration using a passive,“constant-release” rate implant, patch or injection. Some of theseissues have delayed Food and Drug Administration (FDA) approval of theimplant which originally was supposed to occur in 2013. For example, thebuprenorphine dose is fixed and cannot be adjusted to individual needs.(It is known that doses for effective opioid abuse treatment can varysubstantially from individual to individual). Another problem with alllong-acting, constant release devices and formulations is the fact thatthe intensity of opioid withdrawal symptoms and cravings tend to varygreatly with time. It is believed that these alternations areresponsible for patients dropping out at alarmingly high rates, both outof detoxification programs and of long-term maintenance programs. Forexample, a recent study my Morgan et al. have shown that more than 50%of patients on transdermal buprenorphine (BUP) discontinue treatmentwithin 30 days. Long-term studies have shown that after one year, only10% are still using the transdermal patch.

During detoxification, patients are typically in states of greatdiscomfort, pain and emotional distress. In adults relapse occurs oftenbecause the withdrawal symptoms are too severe and not adequatelyrelieved with medication. Thus, there are currently massive unmetclinical needs in the prevention of relapse during both detoxificationand the long-term maintenance treatment. The present invention addressesthis need in the art.

DESCRIPTION OF THE RELATED ART

There are currently no known system that provide continuous monitoring,identification and management of withdrawal symptoms in patients. Inbabies who are born from an addicted mother, withdrawal symptoms, termedNeonatal Abstinence Syndrome (NAS), are complex to detect. Babies withNAS cannot verbalize their condition which makes detection andremediation of the condition more difficult. There are no existingsystems able to monitor for and identify withdrawal symptoms in adultsor in neonates Neonatal Abstinence Syndrome (NAS) and then recommend orprovide a reliable drug treatment intervention. There are also no knownsystems for assisting a recovering drug addict from relapsing.

Generally, the management of withdrawal symptoms or NAS is accomplishedthrough both non-pharmacological and pharmacological interventions. Bothapproaches help treat and decrease the severity of withdrawal symptomssuch as seizures, tachycardia, irritability, sleep problems, high-pitchcrying, increased muscle tone, hyperactive reflexes, poor feeding,diarrhea, dehydration, sweating, fever or unstable temperature, rapidbreathing. Non-pharmacological treatment methods are generally preferredand seek to decrease the patient’s exposure to environmental stimuli.When an infant is being treated these treatments may include things likeswaddling, rocking, gentle handling, demand feeding, and taking care toavoid waking the infant. New studies are showing both pharmacologicaland non-pharmacological approaches are key to treating infants with NAS.

Currently neonates or infants diagnosed with NAS who need apharmacological treatment are sent to a neonatal intensive care unit(NICU) and from there to step-down units (SDUs). Infants admitted in theNICU have a difficult time “rooming in” with mother and require a lowstimuli environment. Infants treated in a pediatric unit, instead of aNICU, tend to require less pharmacological treatment, have a shorterlength of stay and there is a reduced overall health cost in anenvironment that is better suited for the infant.

When no pharmacological treatment is given, NAS infants are at risk ofdeath, not only from lack of treatment for NAS, but, in some instances,from prematurity. Once an addiction condition is identified frominterruption of the placental supply of opiates, pharmacologicalinterventions result in improved survival rates. Currently the mostcommon medications used for NAS treatment include morphine and methadonewith phenobarbital, clonidine, and buprenorphine being used alone or asadjuvant therapy. However, pharmacological management is notstandardized. Medication dosing and weaning varies from medical centerto medical center, and even from clinician to clinician in the sametreatment facility. The threshold for initiating pharmacologicalintervention is questioned by some clinicians and, if treated, thechoice of medication remains controversial.

Treatment of NAS depends upon the clinical presentation of NAS and thepatient’s response to nonpharmacological and pharmacologicalinterventions. How well a patient responds varies significantlydepending upon its gestational age, metabolism, genetic predisposition,and epigenetics. For infants the mother’s choices and health matter aswell as the infant’s treatment depends upon the type, quality, andquantity of any drug the mother used. Whether the mother used selectiveserotonin reuptake inhibitors (SSRIs) and whether the mother enrolled inMedication Assisted Therapy or was a smoker. External factors such aswhether the mother can breastfeed or and room-in with the infant alsomatter. Unfortunately, significant variability persists in thepharmacological treatment given to infants with NAS as well as adultsexperiencing withdrawal symptoms. This variability causes fatalities inan unnecessary number of patients.

To overcome the problems and limitations described above there is a needfor a system that can provide continuous monitoring, identification andremediation of withdrawal symptoms to provide an appropriate drugintervention.

BRIEF SUMMARY OF THE INVENTION

One or more embodiments of the invention are directed to a system thatprovides continuous monitoring, identification and remediation ofwithdrawal symptoms.

One or more embodiments of the invention are directed to a drugtreatment platform that enables a successful reduction of withdrawalsymptoms by providing a system for early recognition and assessment ofwithdrawal severity in NAS babies or adult patients. In doing so on anongoing basis, a more optimized therapy provided in small but effectivedoses is possible. One or more embodiments of the invention are directedto a system for identification and management of opioid withdrawals inneonates at risk of such medical condition. In other embodiments thesystem is adapted to identify and manage withdrawal symptoms in adultpatients. Additional embodiments, or if desired the same embodiment, mayalso be used to help a drug addicted patient from relapsing.

Disclosed in this application is a system for monitoring, identifyingand remediating patient withdrawal symptoms. In one or more embodimentsof the invention the system comprises a wearable device having aplurality of sensors for collecting physiological data from a patient.The plurality of sensors each have a patient contact point for obtainingthe physiological data from the patient. The types of sensors utilizedinclude but are not limited to: a) A pulse ox LED configured to capturea plurality of light wavelengths absorbed differently by a plurality ofoxygenated and deoxygenated hemoglobin molecules from the patient. Thisenables the system to identify a blood oxygen level and record it in thephysiological data. b) A temperature sensor for determining a bodytemperature of the patient and recording the body temperature asphysiological data; c) An accelerometer for determining body movementsof said patient and recording a movement value as said physiologicaldata. The accelerometer determines patient body movement which enablesthe computational device to identify if the patient is experiencing aseizure or tremors. d) An electrode configured to measure a skinimpedance level of the patient which is recorded in the physiologicaldata. A BIOZ electrode, for example, or any other electrode withsuitable functionality may provide the system with the ability tomeasure skin impedance which in turn enables the system to determine thepatient’s perspiration level, breath rate and skin fat levels. Such anelectrode can also be configured to determine the patient’s electrolytelevel with specific ionophores. e) An electromyography (EMG) electrodeconfigured to track the patient’s muscle activity and record a muscleactivity level in the physiological data, f) The system may also utilizean electroencephalogram (EEG) for determining electrical brain activityin the patient which enables the system to identify if the patient isexperiencing a seizure;

This plurality of sensors is configured to send the physiological dataobtained from the sensors to a computational device for processing. Thecomputational device is configured to utilize the physiological data todetermine if the patient is experiencing withdrawal symptoms. Image dataand audio data obtained from the patient can also be evaluated to assesswhether withdrawal symptoms are occurring. Based on the level ofwithdrawal symptoms the system determines a treatment protocol for thepatient.

The wearable device is configured in a form factor that utilizes ahousing cavity within which the sensors described herein may reside.These sensors are removable from the wristband’s housing cavity and canbe placed inside another wearable device. Thus, the wearable device isprovided in an interchangeable form factor that permits reuse of thesensors in different housings or enclosures. This improves the sanitaryaspects of the device and makes the components interchangeable. Anotherkey aspect of the wearable device is that the design accommodatespatients with varying wrist sizes. This is achieved in one mor moreembodiments of the invention using a Velcro strip that can berepositioned through at least one of a plurality of buckles whichenables the wristband circumference to remain adjustable based on thepatient and thereby accommodate various patient wrist sizes. Thus thesame wristband can be utilized for patients having different sizewrists.

In one or more embodiments of the invention the system makes use of aportable structure that is separable from the wearable device. Thisenables the system to be easily moved about so it can be taken intosituation where there are patients in needed of assessment. The portablestructure comprises various elements which enhance the system’s abilityto serve its intended purpose. For example, the system may utilize amounting element configured to hold the computational device. Thismounting device enables users to position the computational device asdesired for ease of use. A camera for obtaining image data of thepatient may also accompany the portable structure. The image data (e.g.,video and/or still images) is sent to the computational device forevaluation in one or more embodiments of the invention. The image datacan be evaluated to determine the patient’s level of movement, bodypositioning, eye movement, facial movement, seizures and/or tremors. Acharge docking station configured to provide a charge to the wearabledevices when the wearable device is coupled with the charge dockingstation may also be included as part of the portable structure. Thewearable devices are coupled to the charge docket via a magnet or someother coupling mechanism that is able to secure the wearable device soit can be charged via a power source. A microphone enables the system topickup audio data from the patient. Various types of microphones areacceptable as long as they capture adequate sound. In one embodiment ofthe invention the microphone is a micro-electromechanical system (MEMS),configured to measure patient audio data to determine cry pitches orother sounds indicative of withdrawal.

When a treatment protocol is determined, the system is able toadminister such to the patient. The system utilizes a medicationreservoir that contains the medications potentially needed forwithdrawal treatment. When a microneedle is attached to the patient thesystem is able to push medication from the medication reservoir to thepatient via the microneedle when called for by the treatment protocol.

A monitoring and predicting NAS diagnosing and delivering treatment forNAS babies comprising: a) inputting a baby’s user information, b)connecting a wearable device to a mobile computing device, wherein saidwearable device is attached to said baby, c) recording, wherein a camerarecords said baby’s NAS symptoms, wherein said baby’s recorded NASsymptoms are stored in said mobile computing device, d) outputting,wherein said wearable device outputs vitals of said baby to said mobilecomputing device, e) displaying vitals of said baby, wherein a datastream is sent from said wearable device to said mobile computingdevice, wherein said mobile computing device displays said vitals, f)calculating, wherein a baby monitoring algorithm calculates a Finneganscore, wherein said baby monitoring algorithm calculates an ESC score,wherein said vitals of said baby are used by said baby monitoringalgorithm to calculate said Finnegan and ESC scores, g) predicting,wherein said Finnegan score and said digitized ESC score are inputted tosaid AI module, wherein said AI module predicts a treatment for saidbaby, and h) delivering, wherein said predicted treatment is deliveredto said baby. The recording mentioned above, wherein said recording ofsaid baby is live. The delivering step discussed above, wherein saiddelivery of said plurality of medications is achieved via a micropump,wherein said micropump pushes said plurality of medications to said babyvia a microneedle.

There are various components to the system implementing one or moreaspects of the invention. These components may include an interactivetechnology such as a tablet, an interactive interface such as an app, adevice or device(s) for data collection and intervention delivery, andan evaluation system for monitoring patient data and determining whenthe patient is exhibiting symptoms requiring intervention in a mannerthat is more effective and more capable than trained medicalprofessionals.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a high-level overview of the system for monitoring,identifying and remediating withdrawal symptoms configured in accordancewith one or more embodiments of the invention.

FIG. 2 illustrates an assortment of data capture devices utilized inaccordance with one or more embodiments of the invention.

FIG. 3 illustrates the functionality of the patient evaluation module inaccordance with one or more embodiments of the invention.

FIG. 4 illustrates how the weighting module functions in accordance withone or more embodiments of the invention.

FIG. 5 is a schematic diagram of an exemplary drug delivery systemconfigured in accordance with one or more embodiments of the inventionto manage patient drug relapses.

FIG. 6 is a schematic illustration of the typical sensors utilized toassess patient withdrawal and/or relapse symptoms.

FIG. 7 illustrates a flow diagram of the decision tree used inaccordance with one or more embodiments of the invention to facilitatedrug release.

FIG. 8 illustrates an integrated neonatal abstinence syndrome (NAS) andwithdrawal monitoring system.

FIG. 9 illustrates the wearable device.

FIG. 10 illustrates the method of monitoring and predicting NASdiagnosing and delivering treatment for babies.

DETAILED DESCRIPTION

One or more embodiments of the invention directed to a system and methodfor monitoring, identifying, and remediating withdrawal symptoms willnow be described. In the following exemplary description numerousspecific details are set forth to provide a more thorough understandingof embodiments of the invention. It will be apparent, however, to anartisan of ordinary skill in the art, the present invention may bepracticed without incorporating all aspects of the specific detailsdescribed herein. Furthermore, although steps or processes are set forthin an exemplary order to provide an understanding of one or more systemsand methods, the exemplary order is not meant to be limiting. One ofordinary skill in the art will recognize the steps or processes may beperformed in a different order, and that one or more steps or processesmay be performed simultaneously or in multiple process flows withoutdeparting from the spirit or the scope of the invention. In otherinstances, specific aspects of the invention well-known to those ofordinary skill in the art are not described in detail so as not toobscure the invention. It should be noted that although examples of theinvention are set forth herein, the claims, and the full scope of anyequivalents, are what define the metes and bounds of the invention.

For a better understanding of the disclosed embodiment, its operatingadvantages, and the specified object attained by its uses, referenceshould be made to the accompanying drawings and descriptive matter inwhich there are illustrated exemplary disclosed embodiments. Thedisclosed embodiments are not intended to be limited to the specificforms set forth herein. It is understood that various omissions andsubstitutions of equivalents are contemplated as circumstances maysuggest or render expedient, but these are intended to cover theapplication or implementation.

The term “first”, “second” and the like, herein do not denote any order,quantity or importance, but rather are used to distinguish one elementfrom another, and the terms “a” and “an” herein do not denote alimitation of quantity, but rather denote the presence of at least oneof the referenced item.

It will be understood that when an element or layer is referred to asbeing “on,” “connected to,” or “coupled to” another element or layer, itcan be directly on, connected to, or coupled to the other element orlayer, or one or more intervening elements or layers may be present.

As used herein, the term “substantially,” “about,” and similar terms areused as terms of approximation and not as terms of degree, and areintended to account for the inherent deviations in measured orcalculated values that would be recognized by those of ordinary skill inthe art. Further, the use of “may” when describing embodiments of thepresent invention refers to “one or more embodiments of the presentinvention.” As used herein, the terms “use,” “using,” and “used” may beconsidered synonymous with the terms “utilize,” “utilizing,” and“utilized,” respectively. Also, the term “exemplary” is intended torefer to an example or illustration.

For the purposes of this application, the words neonatal, baby, babies,infant, infants may be understood to be interchangeable with each other,unless otherwise specified. The term patient is a reference to anyperson who is under observation by a medical caregiver for treatment orpossible treatment. For example, a patient can be a baby, infant oradult person of any age.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which the present invention belongs. Itwill be further understood that terms, such as those defined in commonlyused dictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art and/orthe present specification, and should not be interpreted in an idealizedor overly formal sense, unless expressly so defined herein.

One or more embodiments of the invention will now be described. Aspreviously noted above, current treatments for withdrawal symptoms suchas NAS require the clinical presentation of evident symptoms and thepatient must respond to nonpharmacological and/or pharmacologicalinterventions if they are given. There is significant variability in thepharmacological treatment of patients with withdrawal symptoms and notall patients with the condition are recognized as having it leading toan unreasonably high patient mortality rate. The system and methodsdescribed herein continuously monitoring the patient, identifywithdrawal symptoms and determine an appropriate treatment. Thisobviates the inherent variability in diagnosis and treatment and therebyimproves treatment for patients with withdrawals symptoms such asneonates, infants, babies or newborns with NAS. The system can also beused to help drug addicted patients from relapsing as will be more fullydescribed below.

FIG. 1 illustrates a high-level overview of the system configured formonitoring, identifying and remediating withdrawal symptoms inaccordance with one or more embodiments of the invention. To achieve thedesired impact which is to identify, manage and treat patients withwithdrawal symptoms such as infants with NAS, embodiments of theinvention make use of a wearable device (100) which contains or isconnected with, a collection of one or more sensors or data capturedevices (102). These data capture devices (102) are configured to obtaininformation about the condition of a patient (104) which can be aninfant or adult at risk of withdrawal symptoms. Wearable device (100)accepts patient data (106) from the data capture device(s) (102) andsends it to a patient evaluation module (108) for processing. These datacapture device(s) (102) monitor the patient and collect biomarker datafrom the sensor or observation inputs. The system collects data aboutthe patient’s movement and any audible outputs along with otherinformation subtle enough a trained visual observer would easily miss.These data capture device(s) (102) may be sensors embedded into thewearable device (100) or associated with the wearable device (100). Thiswearable device (100) is paired in one embodiment of the invention witha camera system that monitors behaviors beyond what sensors can provide.Using the camera system, the system can determine body, hand and footmovement and evaluate facial expressions and other movement relatedcharacteristics.

The mobile computing device (116), which can include a smartphone, atablet or an equivalent device, may be used as a patient portal bycaregivers to monitor the journey of patients going through withdrawalsymptoms such as infants experiencing NAS or adults experiencingwithdrawal symptoms. The mobile computing device (116) may displayphysiological biometric and/or behavioral data obtained from thewearable device (100). This wearable device is typically a wrist bandtype device with built in sensors but may also be an ankle band or anyother device that may be worn by the patient. The system may optionallyalso make use of a chest hub or other wearable devices designed toobtain biometric data from the patient and work in conjunction with thewrist band or other appropriate deviceby Artist. The chest hub may havea wireless communication capability so the device can communicate withthe mobile computing device (116), a drug pump, patch, and/or the datacapture devices. The chest hub may have an integrated devices such as adrug pump, respiratory sensor, electrocardiogram (ECG) device and skintemperature monitor for monitoring the patient’s withdrawal symptoms anddetermining a recommended drug intervention. By using the data such asthe ECG, heart rate, and/or temperature the system can predict when aseizure may take place. The combination of various measurements and thecorrelated sensor information provide seizure predictive analytics thatmay be used in combination the other features described herein. An EEGmay be incorporated into the system to enable seizure detection. Acamera system for observing the patient’s movement may also beincorporated into one or more embodiments of the invention. The EEG dataand the camera image data either alone or in combination are evaluatedby the system to determine when the patient is undergoing or may beundergoing a seizure.

The system may include a wearable device such as a monitoring deviceattached to the patient or one that is otherwise able to monitor thepatient. For example, a wearable wrist patch containing sensors able tomeasure physiological biomarkers such as lactate, sweat, tissueoxygenation, and/or movement among other things is incorporated into thesystem in one or more embodiments of the invention. When used, the wristpatch may wirelessly transmit the information it gathers to the system.

The wearable device (100) and/or the mobile computing device (116) maydisplay warning alarms if the patient needs drug intervention or othertreatment. The system may obtain and record a patient assessment ofsymptoms on an ongoing basis or at desired time intervals. Somenon-limiting examples of symptoms displayed on the mobile computingdevice (116) include seizures, tachycardia, irritability, sleepproblems, high-pitch crying, tight muscle tone, hyperactive reflexes,poor feeding, diarrhea, dehydration, sweating, fever or unstabletemperature, rapid breathing. The mobile computing device (116) is incommunication with the wearable device (100) via a network. The networkmay be wireless or wired in any way that enables the devices to readilycommunicate with one another. The biometric and/or behavioral dataobtained by the wearable device (100) via data capture device(s) (102)is communicated to the mobile computing device (116) through thisnetwork connection.

The biometric and/or behavioral data is processed by the patientevaluation module (108) which is also connected to the network in onemore embodiments of the invention. The patient evaluation module (108)is typically where data processing and machine learning algorithmsevaluate the biometric and/or behavioral data however the functionalityof the patient evaluation module (108) may also be implemented on mobilecomputing device (116) or in the cloud in whole or in part.

Further detail about the operability and functionality of the patientevaluation module (108) follows below in FIG. 2 . The patient evaluationmodule (108) utilizes a machine learning component (110) to process andclassify biometric and/or behavioral data (112) as falling withinparameters indicative or not of NAS withdrawal symptoms or adultwithdrawal symptoms. Results of the machine learning component areoptionally subject to user classification feedback (114), which istypically input via the mobile computing device (116) or via any otherinput means.

This expert user feedback enables the system to learn which inputs areindicative of NAS withdrawal symptoms or adult withdrawal symptoms. Thebiometric and behavioral data (112) is sent to an algorithm, which canbe, for example, a supervised machine-learning algorithm such as asupport vector machine with convoluted neural networks to determinewhich symptoms of NAS are active and assess the level of severity of theNAS. Implementing this type of multimodal dataset provides a novelapproach for detecting withdrawal symptoms and behaviors of interestbased on convolutional neural networks (CNN) and support vector machine(SVM). This is accomplished using a system such as Tensorflow or someother machine learning platform. Once the data has been collectedthrough the data capture devices such as a wristband and/or camerasystem, and validated by a clinician and psychometrician, the systemuses this data to construct large sample sets of different kinds ofnon-withdrawal and withdrawal-based symptoms and behaviors as thepositive and negatives of each sample set. This enables the system toidentify the region of interest (ROI). These may be initially validatedwith a biostatistian. A convolutional neural network with a supportvector machine (CNN-SVM) filters the results of the extracted data toreduce the number of negative ROI. Multiple convolutional layers areused to train the dataset to construct the neural network. SVM providesa replacement for the fully connected layer while a softmax classifieris used to classify the sample set based on the training model in order.

As will be more fully described herein, this automated assessmentproduces a score. Depending on how high the score is and what categoriesare scored, medication dosage or non-pharmacological treatments aresuggested to the doctor/nurse’s software screen to show which treatmentis most appropriate and possibly most effective. This is the output inone or more embodiments of the invention. In other embodiments of theinvention the system contains devices enabling the system to alsodeliver the treatment to the patient as the output. These outputs areproduced from the inputs received from the sensors (biometrics) andcamera data (behavioral patterns). These inputs are processed by themachine learning algorithm which can determine an appropriate course ofaction based on the patient data.

The mobile computing device (116) provides an interface for a user toreview the biometric data (112) results and/or to provide userclassification feedback (114). Once the patient evaluation module (108)classifies the biometric data (112) and permits the data to be subjectto the optional user classification feedback (114), a determination ismade as to whether the patient is experiencing opioid use disorder (OUD)-related stress, craving or use (118). If an OUD is identified, thesystem identifies, recommends and/or delivers an appropriate treatmentregime (120) for the patient (104). If an OUD is not identified, thesystem continues to monitor patient (104) and the patient’scorresponding date is captured via data capture device(s) (102).

The mobile computing device (116) performs the functionality describedherein via a software application. This software application has accessto a patient’s biometric and/or behavioral data and enables caregiversto observe and access the patient’s data via a mobile tablet, phone orother mobile computing device. This provides an interface forcontinuously monitoring the patient. For infants that are moved outsideof a Neonatal Intensive Care Unit (NICU) setting this is particularlyimportant as such monitoring does not normally occur outside of a NICUsetting. The software application also provides parents or any otherpermitted user with a way to remotely monitor their baby and vitals.

FIG. 2 illustrates an assortment of data capture devices utilized inaccordance with one or more embodiments of the invention. The datacapture devices are represented in diagram block (200). Various types ofdata capture devices (200) are contemplated as being within the scope ofthe invention. These data capture devices may be incorporated into thewearable device (100) and/or configured to obtain data independently andprovide it to the patient evaluation module (204) as an input (202). Thetype of data capture devices contemplated by the invention are thoseconfigured to collect useful information about the health status of apatient. The patient can be an infant when the system is configured toidentify NAS withdrawal symptoms, but embodiments of the invention canbe adapted to evaluate patients generally and other symptoms as wellbased on data received from the data capture devices (200). Systemsimplemented to identify withdrawal symptoms such as NAS or OUD, containat least one or more of the following types of data capture devices: ablood oxygen monitor (206), a pulse sensor (208), a camera (210) with animage processing module (212) configured to detect body movements, atemperature sensor (214), a respiratory monitor (216), an acousticmonitor (218), an electromyography device (220), and/or an accelerometer(222) for detecting movement. Each of these data capture devices (200)obtains biometric and/or behavioral data about the health of thepatient. The blood oxygen monitor (206) measures the level of oxygen inthe patient’s blood. The pulse sensor (208) determines the patient’sheartrate. The system may also contain a device for determining bloodpressure. The camera (210) is configured to capture images (video and/orstill images) of the patient. These images are used to assess whetherthe patient is experiencing withdrawal symptoms such as NAS or OUD. Onceimages are captured an image processing module (212) determines whetherthe patient is exhibiting NAS and/or OUD characteristics. The imageprocessing module can, for example, observe and determine the patient isexperiencing body movements that would be characterized as restless orout of the ordinary for a normal patient or infant. As a non-limitingexample, the camera (210) may capture facial expressions and body, handand/or foot movement and image processing module can characterize what anurse may not be able to observe as the device is with the patient 24hours a day whereas a nurse cannot typically stay with a patient forsuch a duration. The camera (210) may also capture subtle movements orbehaviors that might otherwise not be ascertained from visualobservation. The camera may for example identify instances of patientrestlessness, seizure or other movement related symptoms.

The temperature sensor (214) measures the temperature of the patient.The respiratory monitor (216) measures a patient’s respiration rate andcan typically measure heart rate as well. The acoustic monitor (218)monitors the decibel level of the patients and can detect subtledifferences in frequency that an untrained human ear cannot typicallydetect. For example, in one embodiment of the invention the acousticmonitor (218) determines the difference between an infant with anexcessively high-pitched cry vs high pitched cry. The electromyographydevice (220) determines the health of the patient’s muscles, and themotor nerve cells that control them and can thereby reveal nervedysfunction, muscle dysfunction or problems with nerve-to-muscle signaltransmission. The accelerometer (222) measures movement of the patientand aids in detecting how frequent and to what extents a patient ismoving about and/or the patient’s general level of restlessness.

The biometric and/or behavioral data obtained from the data capturedevices may be stored on a wearable device, mobile device, on a remotedata source or local computer so it may be utilized as needed to achievethe purpose of the invention. Embodiments of the invention may utilizeadditional data capture devices in situations where additionalinformation contributes to determining a diagnosis or the health of thepatient. These data capture devices are intended to accurately andcontinuously or at least at regular intervals capture the biomarkersspecified in the Finnegan Neonatal Abstinence Score (FNAS). Every datacapture device described herein is not required to implement theinvention and systems may utilize a select one, a select few devices orall devices as input (224) to accomplish the goal of determining if apatient is undergoing withdrawal symptoms. Also, the functionality ofthe various data capture devices may be combined into a unit with suchfunctionality or be contained in separate devices. Generally speaking,having more inputs (224) increases the diagnostic accuracy but theaddition of some inputs are less significant than others and all inputsare not required. Inputs may be added or subtracted based ondeterminations made by the patient evaluation module (108). Once thepatient evaluation module (108) performs its analysis, an output (226)is generated. This output (226) is a probabilistic diagnosis made basedon the input(s) (224) about whether the subject patient is experiencingwithdrawal symptoms such as NAS, OUD or other symptoms.

FIG. 3 illustrates the functionality of the patient evaluation module(108) in accordance with one or more embodiments of the invention. Theevaluation process starts at start block (300) where the system ispowered on and ready to begin processing data. Biosensor data (302) andbehavioral data (303) is obtained by devices able to measure such dataand provided to the patient evaluation module (108). A wristwatch, chesthub and/or other wearable device(s) having one or more of the datacapture devices described in FIG. 2 is one manner this input data may beobtained. The biosensor data (302) is data obtained from any deviceconfigured to obtain biological information from the patient or aboutthe patient. The behavioral data (303) is obtained from data capturedevices able to visually observe the patient and make a determinationabout the patient’s observed behavior. For example, the camera (210) maycapture images and/or video of the patient’s movement and using imageprocessor (212) determine the patient is restless, unable to sleep,and/or experiencing other behaviors indicative of withdrawal symptoms.When at least one of the data capture devices is active and hasbiosensor or behavioral input to evaluate (306), the patient evaluationmodule (108) evaluates this input data to determine how the data is tobe classified (308).

This evaluation system may utilize predictive analytics that improveupon current assessment tools for NAS such as Finnegan NeonatalAbstinence Score (FNAS). These predictive analytics accurately capturesymptoms the patient is having while undergoing NAS or withdrawal,predict appropriate treatments and determine what medication and whatdosage to administer to the patient to treat the withdrawal assessment.

To improve upon the predictive abilities of the system, the system mayutilize a classification process, and receive training inputs (310) froman expert user. Artificial intelligence (“AI”) algorithms are utilizedwhen appropriate as part of the evaluation, classification and/orweighting steps. So the system may determine if the input data, fallswithin a score indicative of there being a need for treatment, aweighted score is assigned (312). If this weighted score (312) fallswithin a treatment threshold, the system outputs a recommendation fortreatment (316) of the withdrawal symptoms. Treatment delivery (318)then begins, and the system continues to actively monitor the progressof the patient by continuing the process. Treatment delivery may occurby an automated means in one or more embodiments of the invention or bya physically administered means in other instances.

As a treatment delivery solution, embodiments of the invention mayutilize a medication cartridge/patch with active drug releasecapabilities. The medication patch is typically a microneedle patch anddrug reservoir that may be attached to the skin or a wearable device sothe drug can be administered in dosages the system determines to beappropriate. The patch may be refilled by a connected micro pump. Themedication/treatment administration need not be automatic but rather mayinclude the approval/acknowledgement from a doctor first before themedication/treatment is administered. In alternative embodiments of theinvention, the medication is automatically delivered based on thesystems determination of the patient’s need. When a drug deliveryplatform is part of the treatment delivery, the system determines whatdrug delivery approach to use based on the severity of withdrawalsymptoms, as determined by the weighted score generated by the system.When the patient exhibits NAS or OUD characteristics the system canrecommend a treatment or administer treatment.

The treatment delivery system may have a closed loop feedback system oropen loop feedback system. The closed-loop feedback system for selectingand administering specific medications to patients (e.g., neonates oradults) may administer, in a controlled manner, with frequencies anddoses determined by a separate control unit. The open-loop feedbacksystem is able to select and administer specific medications topatients, in a controlled manner, with frequencies and doses determinedby a caregiver.

The system may interface with blockchain drug traceability systems andpatient monitoring /electronic health record for secured dataprocessing.

FIG. 4 illustrates how the weighting module functions in accordance withone or more embodiments of the invention. The weighting module (402),which is responsible for assigning the weighted score (312), obtains asinput (400) the classified data obtained from the data capture devices.The weighting module (402) is configured to evaluate this input data anddetermine based on the symptom, a score weight. The exemplary tablebelow, provides an example of the symptoms the system monitors and whenthe symptom occurs, a score weight is assigned to the symptom.

Symptom Score Weight Excessive High-pitched (or other) cry < 5 mins(404) 2 Continuous high-pitched (or other) cry > 5 mins (406) 3Hyperactive Moro reflex (408) 2 Markedly hyperactive Moro-reflex (410) 3High-pitched cry > 2 hours (412) 3 Sleeps < 3 hrs after feeding (414) 1Sleeps < 2 hrs after feeding (416) 2 Sleeps < 1 hrs after feeding (418)3 Mild tremors when disturbed (420) 1 Marked tremors when disturbed(422) 2 Mild tremors when undisturbed (424) 3 Marked tremors whenundisturbed (426) 4 Increased muscle tone (428) 1 Excoriation of skin(430) 1 Myoclonic jerks in sleep (432) 3 Generalized convulsion (434) 5Sweating (436) 1 Hyperthermia: Temperature 37.2-38.3° C. (438) 1Hyperthermia: Temperature >38.4° C. (440) 2 Frequent yawning (442) 1Mottling (444) 1 Nasal stuffiness (446) 1 Sneezing (>3-4 times/scoringinterval) (448) 1 Frantic sucking (450) 1 Nasal Flaring (452) 2 Poorfeeding (454) 2 Regurgitation (456) 2 Projectile vomiting (458) 3 Loosestools (460) 2 Watery stools (462) 3 Tachypnoea >60/minute (464) 1Tachypnoea >60/minute with retractions (466) 2

These weighted scores are fed into the system so a determination can bemade whether the patient is experiencing withdrawal symptoms such asNAS. By utilizing specific input from the data capture devices, thesystem avoids the problem of widespread variation in the scoring whichis what happens when nurses or other medical care professionals are leftto draw conclusion about the patient based on observation only. Whethera cry is “high-pitched” for example, is a matter of subjective opinionwithout decibel information. The system described herein is much moreaccurate than any human is capable of because the system hasquantitative information and can conduct continuous monitoring of thepatient in a manner a human cannot. The system can, for example,classify a cry as high-pitched once the frequency of the cry surpasses800 Hz. A normal cry is 300-500 Hz.

Utilizing the system and methods described herein one or moreembodiments of the invention optimize a drug treatment therapy regime ina way previously not feasible. Having a system able to accurately andcontinuously monitor patients for withdrawal symptoms, assess thewithdrawal severity and recommend or initiate a treatment enables thesystem to save lives and avoid the kind of subpar care patients withsymptoms such as NAS withdrawal symptoms presently experience.

Another aspect of one or more embodiments of the invention is focused onmonitoring for drug relapses. This embodiment provides a drug treatmentplatform that enables a successful reduction of relapses by earlyrecognition and assessment of withdrawal severity followed by swiftadministration of a drug of choice such as buprenorphine (BUP) or otherappropriate drugs in small but effective doses.

This embodiment of the invention can detect a patient’s physiologicalbiomarkers and environmental activities and responding by applyingresponsive therapeutic modalities to manage drug craving orprophylactically treating a patient to prevent or mitigate risk ofoccurrence of relapse. In one or more embodiments of the invention, thesystem is capable of observing clusters of parameters and based on suchparameters recommends a therapeutic intervention such as warning thepatient of a dosing time or automatically administering an effectiveamount of drug to mitigate the risk of relapse. The physiologicbiomarkers may include those associated with opiate withdrawal such asdysphoria, anxiety, restlessness, gastrointestinal distress, tachycardiaand flu-like symptoms.

In another aspect, the invention optimizes the variability of absorptionof a drug to a subject when administered to address patient’s needaccording to her or his individualized needs. Thus, the amountadministered is controlled based on an actual physiological need versusa dosage that is just set by a physician or decided upon by the patient.

As the term is used here, “invasively” means any type of administration,which induces at least a temporary breach in the skin of the subject,including any type of parenteral administration, which, for example, mayinclude, but is not limited to, an intravenous administration or anytype of injection or infusion whether subcutaneous, intradermal,transdermal, intramuscular, intraperitoneal, intrathecal and the like.For the non-limiting, illustrative purposes and ease of the followingdescription only, the below described embodiments relate toadministration of a drug using a pump, for example, a patch or amicroinfusion pump, as described herein. In some embodiments, theinfusion pump can be connected to the subject on a continuous basis. Ascan be understood by one skilled in the art, the pump can be connectedto the patient subject in any other desired way. Some embodiments of thepresent application can be used with transdermal drug delivery as well,although some types of transdermal drug administration can be used fortemporarily breaching the skin of the subject.

In one or more embodiments of the invention, a drug delivery device canbe combined with at least one sensor for measuring parameters that caninfluence patient’s behavior, patient’s drug craving, patient’s mood andbehavioral controls, as well as the drug’s pharmacokinetics and/orpharmacodynamics, including, for example, skin temperature, ambienttemperature, physical activity, local blood perfusion at the druginfused tissue region, and/or others. Embodiments of the invention caninclude one or more additional sensors that measure the above and anyother parameters that can influence drug’s pharmacokinetics and/orpharmacodynamics. In some embodiments, the measured parameters can beused by a controller to calculate an adjustment to the delivered drugdose or rate in order to improve the accuracy and/or the repeatabilityof the desired effect of the delivered drug. The system contemplatesusage of both methadone or other alternatives such as BUP or any otheracceptable treatment dependent upon whether administration of the drughas appropriate medical personnel to handle management of the dosageswhich would be required for methadone vs permitting the patient or thesystem to automatically handle dosing when a prescription is given.

For example, with regard to BUP, the controller can use the measurementinformation to calculate an adjustment to the delivered dose or rate ordelivery profile in order to improve accuracy or repeatability of theeffect. This measurement information can, for example, be used to reducecraving variations during a particular time (e.g., a day). Themeasurement information can also be used to determine specific timeswhere a patient may experience symptoms of withdrawal such asperspiration, increase heart rate, sweating, hallucination, or otherindividually identified behaviors. In one or more embodiments, one ormore sensors can be disposed at the skin to measure degree of sweating,skin temperature or heart rate. In at least one embodiment, theinvention relates to a method for managing craving and behavioralattributes related to opiate or any drug withdrawal. The method includesmeasuring at least one parameter selected from the group consisting of:physiological, biochemical, environmental, and a parameter related tothe drug itself, and adjusting at least one aspect of administration ofthe drug according to the at least one parameter.

The term “drug”, as used herein, is defined to include anypharmaceutically active compound including but not limited to compoundsthat treat diseases, undesirable symptoms, and improve or maintainhealth and prolong drug free life.

Implementation of the methods and apparatus described in the presentdisclosure involves performing or completing certain selected tasks orsteps manually, automatically, or a combination thereof. Moreover,according to actual instrumentation and equipment of some of theembodiments of the methods and apparatuses of the present disclosure,several selected steps could be implemented by hardware or by softwareon any operating system of any firmware or a combination thereof. Forexample, as hardware, selected operations of the methods, apparatuses,systems and devices described herein could be implemented as a chip or acircuit. As software, selected operations could be implemented as aplurality of software instructions being executed by a computer usingany suitable operating system. In any case, selected operations of themethod and system of the present disclosure could be described as beingperformed by a data processor, such as a computing platform forexecuting a plurality of instructions.

Although the present disclosure is described in relation to a “computer”or a “computer network”, it should be noted that any device featuring adata processor and/or the ability to execute one or more instructionsmay be described as a computer, including but not limited to a PC(“personal computer”), a server, a minicomputer, a cellular telephone, asmart phone, a PDA (“personal data assistant”), a pager. Any two or moreof such devices in communication with each other, and/or any computer incommunication with any other computer, may comprise a “computernetwork”.

In one or more embodiments of the invention include long-termmaintenance treatment, since the cause for relapse is not related towithdrawal symptoms, the system provides for a predictive modeling basedon artificial intelligence algorithms that may be used to generateprediction profiles from previous behavioral data that was acquired froma large set of patients. In such an embodiment, a patient memorycapturing of “getting high” and “feeling pleasure” often triggered byenvironmental factors generates cravings that ultimately leads torelapse. As such, healthcare provider, including physicians, can usepredictive algorithms to establish accurate predictions regarding thetherapeutic outcome for individual patients.

In certain embodiments of the invention, integrated devices aredescribed including sensing, monitoring, processing and drug deliverycapabilities which controls both a therapeutic outcome of short (i.e.,detoxification) and long-term drug addiction treatment. The platformused in one or more embodiments of the invention, providesaround-the-clock monitoring of critical physiological signals(“biomarkers”) that quantify the severity of withdrawal symptoms.State-of-the-art sensors can be used that enable minimally invasivemonitoring of patient’s biomarkers. In one embodiment, a smartphone-likeintegrated platform for acquiring physiological and external (e.g. GPSlocation and visual) data in conjunction with a wireless communicationsystem to connect to health care providers are described to provide areal-time monitoring of the patient’s risk of relapse while allowing thehealthcare provider to determine and initiate the clinically suitableresponse. The system can also ascertain when a patient has relapsed sothat professionals can monitor the patient’s status.

FIG. 5 is a schematic diagram of an exemplary drug delivery systemconfigured in accordance with one or more embodiments of the inventionto manage patient drug relapses. As shown, the system can include apatient and provider input system allowing the patient unit control todesignate suitable drug delivery. Module 1 is a diagnostic module (500)configured to sense specific biomarkers and provide an input interface.The diagnostic module contains a patient assisted biomarker sensor(502), an automatic biomarker sensor (504) and may also include apatient input device (506), such as a smartphone-like device withimaging and GPS tracking capability, to allow the patient to directlyinput information. Module 2 is the personalized control unit (508) whereall input data is stored, processed and evaluated. This personalizedcontrol unit (508) controls the drug release system (510) andcommunicates wirelessly with health care professionals (512). Thepersonalized control unit (508) may incorporate an artificialintelligence (‘Al″) module (509) that evaluates the data provided by thediagnostic module (500) and helps inform the recommendation or decisionmaking of the personalized control unit (508). In at least oneembodiment of the invention, the diagnostic module (500) acquires aplurality of real-time data sets that reflect critical physiologicalinformation about the patient’s withdrawal symptoms as specified in theClinical Opiate Withdrawal Scale (COWS). In one example, the dataoriginates from three separate input pathways: (1) Multipleautomatically recorded physiological signals, using non-invasive sensorsand skin probes, including the following: photoplethysmograph (PPG),Galvanic skin response (GSR), temperature, and accelerometer, (2)Patient-initiated measurements, e.g. facial imaging and recordings ofthe eye and nose, using a special smartphone application, (3) a shortsmartphone-based behavioral evaluation to assess the severity ofpsychological withdrawals (anxiety, irritability, depression, dysphoria,etc.).

FIG. 6 is a schematic illustration of the typical sensors utilized toassess patient withdrawal and/or relapse symptoms. In the example given,which is not meant to be exhaustive or at all limiting of what ismonitored on the patient the data the sensor obtains can indicatesymptoms the patient is experiencing. For example, the ECG, pulse rate(600) sensor data may indicate the patient is experiencing tachycardia(614), anxiety (618) or yawning (626). The galvanic skin response data(602) may indicate the patient is having a piloerection (616) orsweating (620). PPG (604) data may indicate patient anxiety. Temperaturedata (606) may indicate a piloerection or sweating (620). Theaccelerometer (608) data may indicate restlessness (622). Facial imaging(610) data may indicate the patient is experiencing runny nose (628),dilated pupils (630), eyes turning (632) and/or dysphoria (634). Aquestionnaire (612) presented to the patient for responses may informthe patient is experiencing an upset gastrointestinal (624) tract ordysphoria (634).

The personalized control unit utilizes a microprocessor to processes andanalyze these multiple data sets from the diagnostic module and/orquestionnaire. The implemented software algorithm in this personalizedcontrol unit will ultimately compute the type and dosage of medicationto be released through the controlled drug release system (510).

This controlled drug release system provides a delivery system thatadministers a given dose of BUP in a precise, well-defined way.Optionally, additional medications (e.g., naltrexone, naloxone,clonidine) or select nutrient solutions can be administered. Medicationsare supplied in disposable, prefilled drug cartridges fortamper-resistant single use. The system uses a micropump that deliversmedication through either a catheter or a microneedle patch to an areaaround the skin where the patch is attached. The pump may be a treatmentoption if all other traditional methods have failed to relieve thepatient’s long-term symptoms. Because the medication is delivereddirectly to the systemic circulation, the withdrawal symptoms can becontrolled with a much smaller dose than is needed with oral medication.The goal of a drug pump is to better control the patient’s symptoms andto reduce oral medications; thus reducing their associated side effectsas well as withdrawal.

The pump is typically a metal or a plastic disposable device about thesize of a hockey puck that is surgically implanted beneath the skin ofthe patient’s abdomen or externally outside of the abdomen with acatheter connected and inserted through the skin. A small plastic tube,called a catheter, is surgically placed in the interstitial space and isconnected to the pump. A space inside the pump called the reservoirholds the medication. The space can hold up to numerous reservoirsaccording to size and shape for all the nutrient and health balancedeficiency that is needed for the patient. The patch is also connectedto the pump via a delivery system such as micro needles. The microneedles can be either passive or active to drive the drug into tissuevia a positive pressure placement pump or actively being charged via awireless method to drive the fluid inside the tissue.

In one or more embodiments of the invention, the pump is programmed toslowly release medication over a period of time. The pump may alsoprogrammed to release multiple other medications such as vitamins aswell as other inflammatory drugs for reducing the side effects ofwithdrawals. It can also be programmed to release different amounts ofmedication at different times of the day, depending on your changingneeds. In other embodiments of the invention, the pump stores theinformation about the patient’s prescription in its memory, and thehealthcare provider can easily review this information to individualizethe drug delivery per patient’s historical needs. In scenarios, when thereservoir is empty, authorized health care providers can refill the pumpby inserting a needle through your skin and into the fill port on top ofthe reservoir.

In one or more embodiments of the invention, the infusion pump iswirelessly connected to an external hardware unit with touchscreeninterface compatible with the pump. A helpful workflow guide may beprovided with simple steps for refill the pump. In other embodiments ofthe invention, the system contains a built-in device able to doauto-calculations for volume and rates or it provides a way to enablethe patients or the healthcare provider to adjust administrationparameters. The system further provides visuals accompany prime bolusand flex dosing to help simplify the process. Various communicators andprogrammers are designed to wirelessly connect enabling flexible andcomfortable delivery of patient care within a desired space.

In one or more embodiments of the invention, the device is not limitedto a single medication, but may be expanded to carry several substancesin individual cartridges for separate, controlled delivery.

In a specific embodiment, a system is described to prevent thedevastating psychological consequences that relapse has for manypatients. A device according to this aspect of the invention is lessinvasive as it is intended to be worn for much longer periods of time(possibly for many years). An integrated smartphone platform, allows thepatient to have access to customized survey tools in an online platformdesigned to enhance accountability and provide patients and stakeholderswith the opportunity to monitor, track and provide early interventionfor noncompliance. In this embodiment, the patient/device interfaceallows the healthcare providers to make real-time behavioral diagnoses.However, as part of an integrated therapeutic device of the one or moreembodiments of the invention, an online support platform grantsauthorized users, healthcare providers or other designated careproviders to release additional doses of the drug of choice, (ex. BUP)quasi instantly, an often psychologically devastating relapse frommaintenance treatment can be avoided. The mathematical algorithm thatsuggests if BUP and in what dose should be released, is based onartificial intelligence, it takes the entire patient’s history with thisdevice and the outcomes of past interventional drug releases etc. intoaccount. At the same time, health care providers will be able tooverride the “decision” of the control unit.

In one or more embodiments of the invention, a drug delivery system canbe configured to deliver a drug to a patient in coordination with aphysiological parameter of the patient (e.g., the patient’s heart rate,piloerection, anxiety levels, sweating, restlessness, GI upset, yawning,dilated pupils, eye tearing, dysphoria, body temperature, or respirationrate). In some embodiments, a drug delivery system can be configured touse a combination of infusion and aspiration to control delivery of adrug to a patient. Catheters, controllers, and other components for usein the above systems are also used, as are various methods of using suchsystems.

In one or more embodiments of the invention, a drug delivery systemincludes a microcatheter having at least one fluid lumen; a pumpconfigured to infuse fluid through the catheter; a sensor configured tomeasure a physiological parameter of a patient; and a controller thatcontrols the pump to coordinate infusion of a drug through the catheterwith the physiological parameter measured by the sensor.

In at least one embodiment of the invention, the controller canharmonize drug administration and frequency with patient’s naturalphysiological parameters and in accordance with modification of suchparameters when patient is at risk of relapse, or craving. In at leastone embodiment of the invention a computer an artificial intelligencecan automatically configure the patient specific parameters ashistorically measured by the sensor to trigger a drug administrationinquiry to an authorized health care provider of record. The controllercan, in one or more embodiments of the invention, synchronizeadministration based on a cluster of parameters prioritized by patient’sspecific physiological response before or after an episode of craving.

In at least one embodiment of the invention, the controller can beoperable in a learning mode in which no administration is performed, andthe controller establishes a correlation between the preidentifiedbiomarkers and patient’s physiological state. The system can include animplantable infusion port in fluid communication with the microcatheter.The microcatheter can include first and second fluid lumens. Thecontroller can be configured to control the pump to alternately aspiratefluid through the first fluid lumen and infuse fluid through the secondfluid lumen in coordination with the physiological parameter measured bythe sensor.

The method of delivering a drug to a patient may include inserting animplantable pump or patch with or without a microcatheter to establishpatient systemic access, measuring a biomarker parameter of the patientusing a sensor; and controlling a pump to coordinate infusion of a drugthrough the patient’s access with the biomarkers measured by the sensor.Again, for the purposes of illustration and without any intention ofbeing limiting, the exemplary drug discussed herein can be a drug foraffecting and/or controlling craving, for example, BUP, naloxone,naltrexone, benzodiazepine or an antidepressant.

FIG. 7 illustrates a flow diagram of the decision tree used inaccordance with one or more embodiments of the invention to facilitatedrug release. In this instance, the drug delivery system comprises apersonalized control unit, a health care provider unit, a controlleddrug delivery pump containing a drug reservoir and supported by ahousing to be placed on a patient and a network communication system.This drug delivery system enables health care professionals to remotelymonitor and manage the drug recovery process by ensuring the patient isadministered a proper dosage of BOU before cravings influence and thendictate the patient’s behavior. When the system is operational (700), itobtains patient data from a biomarker sensor along with optionallyprovided information from the patient (701). If a communication linkwith a managed personal control unit is present (702), the patient datais sent to the managed personal control unit (703). The system defaultsto this as the managed personalize control unit can evaluate the patientdata as a whole and determine based on the patient’s history, if thepatient data indicates a reasonable probability of cravings potentiallyindicative of a relapse (704). This determination makes use in oneembodiment of the invention of an AI learning algorithm that learns thepatient’s behavior patterns and biomarkers so it can assess the relapseprobability and recommend a timely treatment. In other embodiments, AIlearning is not used but the system is pre-programmed with softwarelogic that evaluates the patient data and looks for certain biomarkersand/or behaviors in the patient so it can recommend a timely treatment.Based on the determination made, the personalize control until eitherrecommends a drug intervention or does not (705). When a drugintervention is not recommended the system continues to monitor thepatient and obtain patient data (701). When the system does recommend adrug intervention based on the patient data an optional step of humanreview of the personalized control until recommendation (705) may takeplace. Embodiments of the invention contemplate an open loop systemwherein human review occurs (706) or a closed loop system where humanreview does not occur. If an approval is obtained or the system bypassesthe human approval step, the system sends a drug delivery command to thecontrolled drug release device (707) that is dosed in an amountappropriate for the patient. The controlled drug release device releasesthe drug from the drug reservoir (708) and the system iterates to (700)continue monitoring the patient.

In instances where communication with the managed personalized controlunit is absent, the system adopts a modified approach. If communicationwith the managed personalized control unit is absent (702), the systemcontinues to monitor the patient to determine if the patient dataindicates a potential relapse (709) due to cravings or otherwise. Thisaspect of one or more embodiments of the invention enables the system tofunction in a limited capacity when the patient is off the grid in somecapacity or opts to disable network communications by virtue of theirphysical location or otherwise. When the system determined the patientis offline, there is a need for additional authentication to ensure thepatient is not using the system to obtain additional drug dosages asaddicts sometimes do. Therefore, before any drug treatment isadministered, the system authenticates the patient need (710) for atreatment. This authentication step is configured to evaluate thepatient’s actual need based on a variety of factors. For example, thepatient’s last dosage time, the patient’s biomarker data, the patient’slocation, among other possible relevant inputs are all factors that maybe considered in an authentication decision. Once authenticated, thesystem sends a drug delivery command to the controlled drug releasedevice (707) and the drug is released from the drug reservoir (708).

A first sensor supported by the housing is configured to monitor thepatient for predetermined biomarker levels and obtain a first biomarkerdata set. A second sensor is configured to allow patient assistanceand/or input about biomarker levels in a second biomarker data set. Afirst communication device communicates the first biomarker data set toa processor within the personalized control until. A secondcommunication device communicates the second biomarker data set to theprocessor as well. This second communication device is typicallywireless but can utilize other communication mechanisms as well. Thepersonalized control unit evaluates the first and second biomarker dataset.

FIG. 8 illustrates an integrated NAS and withdrawal monitoring system asit is configured in accordance with one or more embodiments of theinvention. The monitoring system has a multitude of components forsupporting the evaluation of a patient for withdrawal symptoms. Themobile computing device (116) and the accompanying components areassembled into a portable unit that can be moved throughout a medicalfacility for use. This portable unit which contains the mobile computingdevice (116) comprises a charge docking station (804) which provides aninterface for charging each wearable device (100) so it has the powerneeded to monitor patient symptoms, a camera (808) for capturing imagesand/or video of the patient for analysis, an embedded microphone (809)for capturing patient audio data, an optional basket (810) for use bythe medical professionals, a stand (812) that provides for mobility andpositions the device for use while standing, a patient monitoringalgorithm (814) and a clamp (816). The components of the monitoringsystem can be used in any combination to work together as an integratedunit. The monitoring system can be used on NAS patients which includesbabies, neonates, infants or on adults who might be experiencingwithdrawal symptoms. The compactness and portable nature of themonitoring system allows the unit to be used in hospitals, other medicalfacilities, for home use, or in any other environment where having asystem enabled to monitor for withdrawals symptoms would be useful.

In one embodiment the mobile computing device (116) and its accompanyingcomponents is used for determining if babies are undergoing NAS. babies.NAS babies come from mothers, who are addicted drugs, and give birth tobabies who suffer from withdrawal symptoms due to their mother’s drugusage. The mobile computing device (116) utilizes a patient monitoringalgorithm (814) that monitors the patient and calculates both fenniganand eat sleep console (ESC) scores. Based on the data obtained from thismonitoring and calculated fennigan and ESC scores, the system utilizesan artificial intelligence (AI) module able to predict and deliver atreatment to the patient undergoing withdrawal symptoms. It should alsobe noted that the monitoring system is intended to wean off patientsfrom drug withdrawal symptoms by delivering non opioid and painmedications. Data collected from the wearable device (100), camera(808), and/or microphone (809) are provided in one or more embodimentsof the invention as input to the artificial intelligence (AI) module(509) which then utilizes that information to predict a diagnosis anddeliver a treatment to the patient. When a diagnosis is determined, theAI module (509) automates the process of delivering a treatment for thewithdrawal symptoms to the patient. The system can assess when infantsare undergoing NAS as well as determine when adults are experiencingdrug withdrawal symptoms.

The system looks for a variety of symptoms to determine if a baby isexperiencing NAS or an adult is having withdrawals. These symptoms canvary between babies and adults and are also dependent upon the level ofwithdrawal symptoms the patient is experiencing. Symptoms such astremors, seizures, vomiting, excessive yawning and frequent bathroomvisits, for example, are indicative of a patient experiencing withdrawalsymptoms. It should be noted the monitoring system may also includesensing capabilities such as sensing human temperatures, body fat andother types of direct sensing related to the health of a patient whetherthat patient be an infant with NAS or an adult experiencing withdrawalsymptoms.

When the AI module is not utilized, medical personnel can use the datafrom the wearable device (100), and camera (808), which is displayed onthe mobile computing device (116), to determine the best course oftreatment based on the data received on the mobile computing device(116).

FIG. 9 illustrates a wearable device (100) having integrated componentsfor monitoring withdrawal symptoms in patients in accordance with one ormore embodiments of the invention. In this instance, the wearable device(100) comprises components enabling the device to determine when apatient is experiencing symptoms of withdrawal. In one suchimplementation, wearable device (100) comprises an enclosure (803 c), anenclosure cap (803 d), a power source such as a two-slot battery (803e), a protection element (803 f), a power switch (803 g), a printedcircuit board (pcb) (803 h), an embedded electromyography (EMG)electrode (803 b), a BIOZ electrode (803 n), a pulse ox LED (803 o), aglass element (803 i), a surface electrode (803 j), a velcro buckle (803k), a set of pogo pins (803 l), and a wearable device (100) securingmechanism such as a set of buckle pins (803 m), and a strap (803 a). Thewearable device (100) collects data and is configured to securely outputinformation to the wearable device (100). The enclosure cap (803 d)encapsulates the power source, which in this example is a two-slotbattery (803 e) as well as the pcb (803 h). The two-slot battery (803 e)can hold two batteries thereby providing the wearable device (100) witha longer runtime before additional power or a recharge is required.Other power sources and other battery configurations that provideadequate power as needed are also well within the scope contemplated aspart of the invention described herein. The power switch (803 g) allowsthe system to be shut off or turned on for operation. The sensorsembedded in the wearable device (100) are integrated on the pcb (803 h)which may be placed inside the enclosure cap (803 d). The enclosure cap(803 d) is a housing that protects the pcb (803 h), also protects theglass element (803 i) and the different sensors that are placed on thepcb (803 h). The enclosure cap (803 d) enables the wearable device (100)to be robust against user wear and tear. The integration of the sensorsallows for a compact design which decreases the size and weight of thewearable device (100). The surface electrodes (803 j) may also bemounted on the pcb. The protection element (803 f) is a structure thatprovides an additional layer of protection for the pcb (803 h) sensorsand the power source. The velcro buckle (803 k) is configured to wraparound said patient’s wrist and allows for enables the strap (803 a) tobe adjustable so that a variety of patients can comfortably wear thewearable device (100). Other wearable devices (100) such as a wearabledevice (100) securing mechanisms can also be used to secure the wearabledevice (100) to the patient. The pogo pins (803 l), connect the pcb (803h) to the glass element (803 i). It should be noted that the glasselement (803 i) is connected to the pcb (803 h) via pogo pins (803 l).In order for the sensors and surface electrodes (803 j) to functionfully, said sensors and surface electrodes (803 j) have to make phycialcontact with the glass element (803 i). The buckle pin (803 m) isconnected to the velcro buckle (803 k). The pogo pins (803 l) are placedin a recessed cavity to protect the patient’s skin from touching thecharging pins and to reduce the possibility of electrical shock. Arecessed cavity creates a recess for a magnetic connector to have asolid electrical connection. Additionally, the recessed cavity ishelpful to prevent the EMG (803 b) and BIOZ (803 n) electrodes fromfunctioning incorrectly due to an electrical shortage.

The wearable device (100) contains sensors for collecting differentphysiological signals from the patient. Using these sensors, thewearable device (100) monitors the patient’s heart rate, oxygensaturation, movement, body temperature, perspiration, muscle activityand/or other important vitals.

The strap (803 a) that contacts the wrist of a patient is typically madefrom silicone rubber or other material that is medical and food-grade.This material is advantageous because silicone rubber is skin-contactsafe, durable, versatile, and biocompatible (USP Class VI, ISO10993).The strap (803 a) characteristic is particularly helpful for patientssince the patient can be an infant where skin-contact safety is animportant quality of the wearable device (100). The wearable device(100), in one or more embodiments of the invention, are made from asingle scratch resistant sapphire crystal, increasing the life of thewearable device (100). In addition, the wearable device (100) sensor(803) may have an embedded electromyography (EMG) electrode (803 b) usedto track patient muscle activity. This in turn will aid in detectingneurological movement disorders such as seizures, tremors, overactivereflexes, and other neurological movements. The BIOZ electrode (803 n)provides doctors safe, noninvasive access to information about apatient’s heart’s ability to deliver blood, how hard the patient’s heartis pumping, and the amount of fluid is in the patient’s chest. The BIOZ(803 n) and EMG (803 b) electrodes operate simultaneously withoutaffecting or interfering with each other. The BIOZ (803 n) and the EMG(803 b) electrodes are physically isolated from each other which resultsin reduced electrical noise caused by each different sensor in thesystem.

The pulse ox LED (803 o) is a sensor with a light-emitting diode (LED)connected by a cable to an oximeter. The LED emits light wavelengthsthat are absorbed differently by oxygenated and deoxygenated hemoglobinmolecules. The more hemoglobin saturated by oxygen, the higher theoxygen saturation. The pulse detection is shown by a green LED, thatgreen LED is placed closer to the temperature sensor (214). The greenLED is larger and consumes more DC power than the other color LEDs whichcompensates for the lower skin penetration. The red and green LEDs areplaced a reasonable distance from the temperature sensor (214) to reducethe effect on temperature readings. A physical divider separates thetemperature sensor (214) from the pulse Ox LED (803 o). This in turnreduces interference from the LED light as the LED light can affect themeasurement performance of the temperature sensor (214).

The charge docking station (804) is mounted on a stand (812). The chargedocking station (804) is used to electrically charge and dock the mobilecomputing device (116) as well as the wearable device (100). Inaddition, the charge docking station (812) can be utilized to charge twoor more wearable devices (100) at a time thereby allowing for the use ofmultiple wearable device (100) for the monitoring of multiple patients.

The batteries in the wearable device (100) contain thermal safetydetection such that if the battery temperature starts to rise above asafe level, the monitoring system is disconnected from the battery toallow the system to return to a safe temperature before safelyreconnecting to the wearable device (100) and resuming normalfunctionality. The wearable device (100) has dual slots for theplacement of two batteries and can as a result function after thefailure of one battery. This characteristic allows for longeroperational time for a given patient or patients. In addition, thewearable device (100) also contains a small memory backup component forstoring data during communication failure. When communication with themobile computing device (116) is re-established, the wearable device(100) uploads missing data back into the wearable device (100). Todiagnose possible issues with the wearable device (100), an errorcollection system logs and analyzes possible wearable device (100)failures. When a critical failure is detected, the wearable device (100)automatically powers down and thereafter a message is sent to thewearable device (100) to notify the medical professional of the issue.

In addition to the wearable device (100) collecting data from thepatient, the camera (808) also records the patient’s behavior (808) andthereby creates a video and audio data that is stored and is viewable onthe mobile computing device (116). Different behaviors indicatedifferent NAS symptoms in a patient which can be useful to a medicalprofessional or to the AI module (509). The camera (808) is connected tothe charge docking station (804) and can transmit data to the wearabledevice (100). In addition, the camera (808) has an embedded microphone(809), wherein the microphone (809) is configured with a digitalmicro-electromechanical system (MEMS) which is configured to measure lowaudible sounds. It should be noted that there are different microphones(809) placed in the camera (808). These different microphones (809) areconfigured to pick up different pitches of a NAS patient. The differentmicrophones (809) for different pitches allow the monitoring system tohave the ability identify, record and analyze a wide variety ofdifferent sounds that may come from NAS patients or patientsexperiencing adult drug withdrawal symptoms.

The mobile computing device (116) displays readings and battery levelsfrom the wearable device (100) as well as the data from the camera(808). In addition, the wearable device (100) contains software thatallows the user to manually input Finnegan and eat, sleep and console(ESC) symptoms to calculate scores and visualize the data.

It should be noted loss of confidentiality is low risk because thewearable device (100) automatically anonymizes the data communicatedfrom or going to the wearable device (100). The network server connectedto the monitoring system is configured to be accessed by approvedpersonnel verified with multi factor authentication. Identifiableinformation collected is automatically removed thereby insuringconfidentiality.

The patient monitoring algorithm (814) embedded in the mobile computingdevice (116), allows the mobile computing device (116) to collect frommultiple sensors at the same frequency. The algorithm has beenoptimized, in accordance with one or more embodiments of the invention,to collect data from each sensor at the minimum rate to extractinformation from the sensors. Additionally, the firmware is optimizedfor battery life to increase the time between charging and extended themaximum possible data recording session. In addition, a Bluetoothcommunication system is used to increase the maximum data throughputpossible while reducing the number of communication packets required,increasing the device efficiency.

FIG. 10 illustrates a method for using the wearable device (100), thecamera (808) and mobile computing device (116) to predict withdrawalsymptoms such as NAS or otherwise and deliver treatment to a patient.Initially, a patient who is to undergo evaluation (1000) is associatedwith the system. This is accomplished by obtaining patient data from adata source typically via an input mechanism where the patient data isprovided by a medical professional. In other instance the patient datais obtained from a database or patient medical record. To utilize thesystem the mobile computing device (116) is wirelessly connected (1002)to the wearable device (100) and the wearable device (100) is placed onthe patient so monitoring may begin.

While the device is being worn by the patient the sensors in thewearable device (100) actively evaluate the patient for symptoms. Whensensor data is received (1004), such as data from the embeddedelectromyography (EMG) electrode (803 b), a BIOZ electrode (803 n), or apulse ox LED (803 o), the system records (1006) this data forevaluation. This recorded data is sent from the wearable device (100) tothe mobile computing device (116).

A patient monitoring algorithm (814) uses the recorded data to calculate(1008) the Finnegan and ESC scores respectively. For context,traditionally medical personnel use paper forms to manually check offsymptoms patients exhibit to properly treat them. The process isinherently flawed in that symptoms are observed in an intermittent andirregular fashion and the opinion or experience of the observerinherently factors into the scoring. After filling out the form based ontheir observations medical professionals calculate the score. Treatmentvaries depending on the score. It should be noted that manually scoringof the Finnegan and ESC is inconsistent nurse to nurse or from doctor todoctor. This can lead to inconsistent care for NAS babies or adultsexperiencing withdrawal symptoms. By calculating the Finnegan and ESCscores, the system enables patients to get more consistent care bymedical personnel and the result is a better outcome for the patientbecause a more precise and consistent calculation of the Finnegan andESC scores is utilized.

The monitoring system is able to capture image data from camera (808)recording patient movement and behaviors (1010). The camera (808)records the patient’s symptoms. The recorded image data is typicallystored in the mobile computing device (116) or a data repositoryaccessible to the mobile computing device (116).

If data output is requested or the system is setup to do such (1012),the recorded data, which provides information about the patient’svitals, can be displayed on the mobile computing device (116) or outputas desired for live or subsequent review (1014). The display provides anintended user a user friendly and convenient way to review patientinformation. The system display provides a continuous summary of theFinnegan and ESC score throughout the day. The mobile computing device(116) also has a dashboard which displays information about the healthcare personnel, the patient, and manuals.

This typically involves storing symptom data for usage by the system.

The sensor data and/or image data is utilized to evaluate the patient todetermine if NAS or drug withdrawal symptoms are occurring (1016). Thisinformation and the result of any determination or prediction made isrecorded for subsequent action and/or diagnosis.

In one or more embodiments of the invention, the recorded data isevaluated by an Al module (509) to predict (1016) the status of thepatient and make determinations about an appropriate treatment (1018).Once an appropriate treatment is identified, the system delivers (1020)the given does of BUP in a precise manner. Optionally, additionalmedications may be administered such as Kratom (Mitragynia SpeciosaKorth) or Kratom extract such as mitragynine, psuedoindoxyl,7-hydroxymitragynine. Medications may also include but are not limitedto, benzodiazepines, anti-seizure, anti-depressant, vitamins andminerals, pain medications. The system uses a micropump to deliver theabove medications through either a catheter or a microneedle patch to anarea of the skin where the patch is attached.

It should be noted that when delivering the medication to a NAS patientor patient experiencing withdrawal symptoms, the treatment is applied bythe sensing mechanism as according to the AI module (509) prediction asdiscussed above. The end goal of the monitoring system is to be freefrom or substantially reduce the need for medical personnel since thesystem will monitor, calculate, record, predict and deliver theappropriate amount of medication based on the AI prediction module (509)without the assistance of medical personnel.

The system may record non-pharmacological treatment methods that wereused as well as dosing and medication details for pharmacologicaltreatments. Conducting ESC and Finnegan score calculating (1008) on anongoing basis enables the mobile computing device (116) to displayinformation for medical professionals to answer questions in order togenerate an outcome. The system continues to monitor the patient asneeded until treatment is no longer required.

Thus, a system and methods for identifying and remediating patientwithdrawal symptoms utilizing artificial intelligence analysis of thecollected patient data has been described. It should be noted thatalthough examples of the invention are set forth herein, the claims, andthe full scope of any equivalents, are what define the metes and boundsof the invention.

1. A system for monitoring, identifying and remediating patientwithdrawal symptoms comprising: a wearable device having sensors forcollecting physiological data from a patient; said sensors having apatient contact point for obtaining said physiological data from saidpatient, said sensors being configured to send said physiological datato a computational device; and said computational device configured tosend said physiological data to an artificial intelligence (‘AI”) modulefor a determination whether said patient is experiencing withdrawalsymptoms.
 2. The system of claim 1 wherein said sensors comprise: apulse ox LED, wherein said pulse ox LED emits a plurality of lightwavelengths absorbed differently by a plurality of oxygenated anddeoxygenated hemoglobin molecules from said patient; a temperaturesensor for determining a body temperature of said patient; anaccelerometer for determining body movements associated with saidpatient; an electrode configured to measure a skin impedance level ofsaid patient; and an electromyography (EMG) electrode, wherein said EMGelectrode is configured to track said patient’s muscle activity.
 3. Thesystem of claim 2 wherein said EMG comprises at least three surfaceelectrodes which come in contact with a skin surface of said patient. 4.The system of claim 2 wherein said BIOZ electrode comprises at least twosurface electrodes which come in contact with a skin surface of saidpatient.
 5. The system of claim 1 further comprising: anelectroencephalogram (EEG) for determining electrical brain activity insaid patient.
 6. The system of claim 5 wherein said electrical brainactivity from said EEG enables said computational device to identify ifsaid patient is experiencing a seizure.
 7. The system of claim 1 whereinsaid accelerometer for determining body movements associated with saidpatient provides movement data enabling said computational device toidentify if said patient is experiencing a seizure or tremors.
 8. Thesystem of claim 1 wherein said electrode configured to measure saidpatient’s skin impedance level comprises a BIOZ electrode.
 9. The systemof claim 8 wherein said BIOZ electrode provides said skin impedancelevel to enables said computational device to determine said patient’sperspiration level.
 10. The system of claim 8 wherein said BIOZelectrode provides said skin impedance level to enables saidcomputational device to determine said patient’s breath rate.
 11. Thesystem of claim 8 wherein said BIOZ electrode is used to determine saidpatient’s electrolyte level with specific ionophores.
 12. The system ofclaim 8 wherein said BIOZ electrode provides said skin impedance levelto enables said computational device to determine said skin fat levels.13. The system of claim 1 further comprising: a glass element, whereinsaid glass element is attached to an enclosure cap, wherein said glasselement protects said sensors on a printed circuit board.
 14. The systemof claim 1 wherein said sensors are removable from said wristband. 15.The system of claim 14 wherein said wearable device is aninterchangeable form factor such that said sensors are reusable in asecond wearable device.
 16. The system of claim 1 wherein said wearabledevice further comprises: a wristband comprising a velcro stripconfigured to be adjustably repositionable through a plurality ofbuckles on said wristband to wraparound said patient’s wrist andaccommodate varying wrist sizes of said patient.
 17. The system of claim1 wherein said wearable device further comprises a charging interface toprovide power to said wearable device.
 18. A system for monitoring,identifying and remediating patient withdrawal symptoms comprising: awearable device having a plurality of sensors for collectingphysiological data from a patient, said plurality of sensors each havinga patient contact point for obtaining said physiological data from saidpatient; said plurality of sensors comprising: a) a pulse ox LEDconfigured to capture a plurality of light wavelengths absorbeddifferently by a plurality of oxygenated and deoxygenated hemoglobinmolecules from said patient and identify a blood oxygen level recordedas said physiological data; b) a temperature sensor for determining abody temperature of said patient and recording said body temperature assaid physiological data; c) an accelerometer for determining bodymovements of said patient and recording a movement value as saidphysiological data; d) an electrode configured to measure a skinimpedance level of said patient which is recorded as said physiologicaldata; e) an electromyography (EMG) electrode configured to track saidpatient’s muscle activity and record a muscle activity level as saidphysiological data; said plurality of sensors being configured to sendsaid physiological data to a computational device; a portable structureseparable from said wearable device, said portable structure comprising:a) a mounting element configured to hold said computational device; b) acamera for obtaining image data of said patient which is sent to saidcomputational device; a charge docking station configured to provide acharge to said wearable devices when said wearable device is coupledwith said charge docking station; c) a microphone to pickup audio datafrom said patient, wherein said microphone is a micro-electromechanicalsystem (MEMS), configured to measure said audio data to determine crypitches of said patient; and wherein said computational device isconfigured to utilize said physiological data, said image data, and saidaudio data to determine if said patient is experiencing withdrawalsymptoms and based on said withdrawal symptoms determine a treatmentprotocol for said patient.
 19. The system of claim 18 wherein saidcomputational device utilizes said image data of said patient todetermine said patient’s level of movement, body positioning, eyemovement, facial movement, seizures and tremors.
 20. The system of claim18 further comprising: a medication reservoir; a microneedle attached tosaid patient; a micropump, configured to push medication from saidmedication reservoir to said patient via said microneedle when calledfor by said treatment protocol.